NEW YORK – The European Commission on Thursday approved Bristol Myers Squibb's anti-BCMA CAR T-cell therapy idecabtagene vicleucel (Abecma) for patients with relapsed and refractory multiple myeloma who have received at least three prior therapies.
Ide-cel was granted conditional marketing authorization under the European Medicines Agency PRIME, or priority medicines, scheme. The conditional approval is valid for one year and can be converted to full marketing authorization once additional data is submitted and assessed.
The conditional approval was based on data from the Phase II KarMMa trial. That study included 128 patients with relapsed and refractory multiple myeloma who had received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. In the study, 77 percent of patients responded to treatment with ide-cel and 33 percent achieved a complete response. The median duration of response was 10.6 months for the whole study population and 23 months for those who achieved a complete response.
"In the KarMMa trial, treatment with ide-cel proved to elicit deep and durable responses in a significant proportion of patients with triple-class exposed multiple myeloma, including many who were heavily pretreated and had high-risk disease," Jesus San Miguel, KarMMa clinical trial investigator and medical director of the Clinica Universidad de Navarra, in Navarra, Spain, said in a statement. "The approval is important for patients in Europe, as it represents another potential therapeutic option for clinically meaningful outcomes and long-term disease control."
With the approval, BMS is also looking to expand its manufacturing capability of ide-cel to Europe with plans to add a manufacturing facility in Leiden, Netherlands. The company is also working on treatment center qualification and onboarding and completion of reimbursement procedures to launch ide-cel in the EU.
In March, the US Food and Drug Administration approved ide-cel for a slightly modified indication, relapsed or refractory multiple myeloma patients who have previously received at least four lines of treatment. The CAR T-cell therapy was also approved in Canada in May for relapsed or refractory multiple myeloma patients who have received three prior therapies.